Phase
Condition
Hiv
Treatment
PGDM1400LS (SC)
ePGT121v1-LS (IV)
ePGT121v1-LS (SC)
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18 to 55 years.
Can visit a participating clinic and is willing to stay in the study for its fullduration.
Understands the study and is able and willing to give informed consent.
Agrees not to join another experimental study until the final required clinic visit.
In good overall health based on medical history, physical exam, and screening labtests.
Willing to receive HIV test results.
Willing to discuss personal risk of getting HIV and to have HIV preventioncounseling.
Judged by clinic staff to have a low risk of getting HIV and agrees to avoid higherrisk behaviors through the last clinic visit.
Hemoglobin levels:
Women: at least 11.0 g/dL
Men: at least 13.0 g/dL
White blood cell count between 2,500 and 12,000 cells/mm³.
White blood cell differential is normal or acceptable to clinic staff.
Platelet count between 125,000 and 550,000 cells/mm³.
ALT (liver enzyme) less than 1.25 times the lab's upper limit of normal.
Creatinine (kidney test) less than 1.1 times the lab's upper limit of normal.
Negative tests for HIV 1 and HIV 2.
Negative hepatitis B surface antigen.
Negative hepatitis C antibody, or a negative HCV PCR if the antibody test ispositive.
Urine protein is negative or only trace.
If a woman who could become pregnant: negative pregnancy test within 72 hours beforethe first study treatment. Women with a documented total hysterectomy, both ovariesremoved, both fallopian tubes removed, or menopause (no periods for at least 1 year)do not need pregnancy testing.
Women who could become pregnant agree to use effective birth control for sex thatcould lead to pregnancy starting at least 21 days before enrollment and continuingthrough the last study visit.
Women who could become pregnant also agree not to try to become pregnant usingmethods like egg retrieval, artificial insemination, or in vitro fertilizationstarting at least 21 days before enrollment and continuing through the last clinicvisit.
Exclusion
Exclusion Criteria:
Received blood products within 120 days before the first study dose (unless thesafety review team approves earlier enrollment).
Took any experimental (investigational) research drug within 30 days before thefirst study dose.
Weighs less than 35 kg or more than 115 kg.
Plans to join another study using an experimental product, or any study thatrequires non Network HIV antibody testing, during this study.
Pregnant or breastfeeding.
Previously received an HIV vaccine in a vaccine trial. If a potential participantreceived placebo/control only, eligibility will be decided case by case by thesafety review team.
Received any non HIV vaccine within 14 days before enrollment or plan to get onewithin 14 days after enrollment. Exception: ACAM2000 smallpox vaccine within 28 daysbefore enrollment (or scab still present if earlier) or planned within 14 days afterenrollment.
Received humanized or human monoclonal antibodies (mAbs), whether approved orexperimental.
Previously received monoclonal antibodies that target HIV.
Receiving allergy shots within 30 days before the first study dose or scheduledwithin 14 days after the first dose.
Took immune suppressing medicines within 30 days before the first study dose. Notexcluded: nasal steroid sprays; inhaled steroids (see asthma item); topical steroidsfor mild skin conditions; or one short course of oral/IV prednisone (less than 20mg/day for under 14 days) finished at least 7 days before the firstinfusion/injection.
History of serious reactions to components of the study products, includinganaphylaxis or symptoms like hives, trouble breathing, swelling (angioedema), orabdominal pain.
Received immunoglobulin within 60 days before the first study dose (separate frommAbs listed above).
Autoimmune disease that is not mild, stable, and uncomplicated. Mild, stable casesnot needing immune suppressing drugs may be allowed if the investigator judges lowrisk.
Immunodeficiency.
Any significant medical issue, abnormal exam or lab result, or past condition thatcould:
Affect the immune system or its response,
Require medicines that affect the immune system,
Make repeated injections, infusions, or blood draws unsafe or not feasible (forexample, very difficult veins),
Need active medical care to prevent serious harm during the study,
Have symptoms that could be mistaken for reactions to the study product,
Or is otherwise listed among these exclusions.
Any medical or skin condition, social situation, or job duty that, in theinvestigator's judgment, would interfere with following the study, safetyassessments, or giving informed consent.
A psychiatric condition that prevents following the study. Specifically excluded:psychosis, current suicide risk, or a suicide attempt within the past 3 years.
Currently on tuberculosis treatment.
Asthma that is more than mild and well controlled.
Diabetes (type 1 or type 2). Not excluded: type 2 controlled with diet only, or apast history of gestational diabetes.
High blood pressure (hypertension).
Diagnosed bleeding disorder.
Cancer. Not excluded: surgically removed cancers with good assurance of cure or verylow risk of recurrence during the study period.
Seizure disorder with any seizure in the past 3 years, or use of seizure preventionor seizure treatment medicines at any time in the past 3 years.
Asplenia (no functioning spleen).
History of widespread hives, swelling (angioedema), or anaphylaxis. Not excluded ifdue to a known trigger and there have been no reactions for at least 5 years,showing successful avoidance of the trigger.
Study Design
Connect with a study center
Via Libre CRS (Site ID: 31909)
Lima Cercado, Lima region 15001
PeruSite Not Available
Via Libre CRS (Site ID: 31909)
Lima Cercado 9863490, Lima region 3936452 15001
PeruSite Not Available
Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) (Site ID: 31970)
Bellavista, Provincia Constitucional del Callao 07006
PeruSite Not Available
Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) (Site ID: 31970)
Bellavista 3946756, Provincia Constitucional del Callao 3946080 07006
PeruSite Not Available
Alabama CRS (Site ID: 31788)
Birmingham, Alabama 35222
United StatesActive - Recruiting
Alabama CRS (Site ID: 31788)
Birmingham 4049979, Alabama 4829764 35222
United StatesSite Not Available
Bridge HIV CRS (Site ID: 30305)
San Francisco, California 94102
United StatesActive - Recruiting
Bridge HIV CRS (Site ID: 30305)
San Francisco 5391959, California 5332921 94102
United StatesSite Not Available
George Washington University CRS (Site ID: 31608)
Washington D.C., District of Columbia 20052
United StatesSite Not Available
George Washington University CRS (Site ID: 31608)
Washington D.C. 4140963, District of Columbia 4138106 20052
United StatesSite Not Available
The Ponce de Leon Center CRS (Site ID: 5802)
Atlanta, Georgia 30308
United StatesSite Not Available
The Ponce de Leon Center CRS (Site ID: 5802)
Atlanta 4180439, Georgia 4197000 30308
United StatesSite Not Available
Brigham and Women's Hospital Vaccine CRS (BWH VCRS) (Site ID: 30007)
Boston, Massachusetts 02115
United StatesSite Not Available
Brigham and Women's Hospital Vaccine CRS (BWH VCRS) (Site ID: 30007)
Boston 4930956, Massachusetts 6254926 02115
United StatesSite Not Available
Penn Prevention CRS (Site ID: 30310)
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Penn Prevention CRS (Site ID: 30310)
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
Vanderbilt Vaccine (VV) CRS (Site ID: 30352)
Nashville, Tennessee 37232
United StatesActive - Recruiting
Vanderbilt Vaccine (VV) CRS (Site ID: 30352)
Nashville 4644585, Tennessee 4662168 37232
United StatesSite Not Available
Houston Advancing Research Team CRS (Site ID: 31473)
Houston, Texas 77030
United StatesSite Not Available
Houston Advancing Research Team CRS (Site ID: 31473)
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available

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